Clinical Trials in Korea

Transcription

1 Clinical Trials in Korea Yung-Jue Bang, M.D., Ph.D. Vice-President, Korea National Enterprise for Clinical Trials Director, Clinical Trials Center, Professor, Division of Medical Oncology, Seoul National University Hospital

2 Clinical trials for registration before 2000 Korean GCP KFDA

3 Driving forces for changes : Comprehensive discussions among regulatory authorities, industry and academia KFDA - successful progress of ICH meetings Domestic pharma companies - new agents to be tested Foreign pharma companies - new drugs to be launched Academia - highly motivated clinical investigators 2000 : Bench-marking visit of Australia 3

4 Major regulatory changes in early 2000s KGCP revision, as of January 4, 2000 Harmonize with ICH guideline E6 Clarify the responsibility of investigators and the function of IRB Adoption of the Bridging concept (E5) in 2001 Diverse bridging strategies were permitted Separation of IND from combined IND/NDA in

5 National Technology Roadmap Project* for clinical trial technology Experts Working Group recommend globalization of clinical trials. Establishing Centers of Excellence Developing educational/training programs for clinical trial professionals International accreditation of IRBs Regulatory reforms * by MOST & MOHW, in 2002

6 Upgrading IRBs Korean Association of IRB (KAIRB) in 2002 Non-profit organization with more than 50 IRBs IRB operation guidelines, SOP Education of IRB professionals In 2007, endorsement from MOHW for training of IRB professionals International accreditation of IRBs Samsung Medical Center in 2006* Seoul National University Hospital, Asan Medical Center in 2006^ Inje University Busan Hospital, Seoul St. Maria Hospital, Chonnam University Hospital in 2007^ 14 IRBs as of 2009 * By AAHRPP, ^ by SIDCER/FERCAP

7 KFDA: Streamlining of IND review system Reduced IND approval time in Korea days KFDA database New Regulations year

8 Regional Clinical Center by MOHW Similar to US NIH-GCRC supporting program 14 centers of excellence ( ) centers centers centers centers centers

9 Clinical Trials Center, SNUH Established on June 15, 1997 Designated as Regional Clinical Trials Center by MOHW in 2004 Renovation in 2007

10 Clinical Trials Center, SNUH Core lab.: sample processing/storage Research ward: 46 trial beds Outpatient clinic: 7+1 units Pharmacy Pharmacodynamics lab. Medical Device Evaluation

11 Korea National Enterprise for Clinical Trials (KoNECT) in

12 Activities of KoNECT Regional Trials Centers 2009 : 14 regional trials centers KoNECT Program Human Resources Academy education centers, 8 Programs Clinical Investigators, Clinical Pharmacologist CRA, CRC, Biostatistician, DB manager, Clinical Trial Pharmacist, etc New Technology projects 12

13 Globalization of clinical trials; trends Korea 9.5; 17.9% NATURE REVIEW 2008;7:13-14

14 Clinical trials approved by KFDA Multi-national Local KoNECT Regional Clinical Trial Centers IRB Fellowship ICH Harmonization ICH-GCP IND separation

15 Clinical trials by country Source: Dec (Total ) 2006 (119085) 2007 (115975) 2008 (142597) 2009 (96497) 1 US % US % US % US % US % 2 Canada % Germany % Germany % France % France % 3 Germany % France % France % Germany % Germany % 4 France % Canada % Canada % Canada % Canada % 5 UK % UK % UK % Japan % Spain % 6 Italy % Spain % Spain % Italy % Belgium % 7 Japan % Italy % Italy % Spain % UK % 8 Spain % Japan % Japan % UK % Italy % 9 Netherlands % Poland % Poland % Russia % Japan % 10 Australia % Australia % Belgium % Belgium % Korea % 11 Belgium % Netherlands % Russia % Poland % China % 12 Poland % Russia % Australia % Netherlands % Russia % 13 Sweden % Belgium % Netherlands % Korea % Poland % 14 Denmark % Brazil % India % Australia % Australia % 15 Norway % India % Hungary % India % Netherlands % 16 Russia % Argentina % China % China % India % 17 Czech Republic % Czech Republic % Brazil % Czech Republic % Brazil % 18 South Africa % Austria % Korea % Brazil % Sweden % 19 Brazil % Israel % Czech Republic % Sweden % Switzerland % 20 Hungary % Sweden % Israel % Hungary % Hungary % 21 Switzerland % Hungary % Sweden % Austria % Israel % 22 Taiwan % Denmark % Austria % Israel % Austria % 23 Finland % Mexico % Argentina % Denmark % Denmark % 24 Mexico % Korea % Ukraine % Romania % Taiwan % 25 Argentina % South Africa % Mexico % Argentina % Czech Republic % 26 India % China % Denmark % Mexico % Mexico % 27 Israel % Ukraine % Switzerland % South Africa % Slovakia % 28 Austria % Switzerland % Taiwan % Greece % Romania % 29 China % Romania % South Africa % Taiwan % Finland % 30 Greece % Finland % Greece % Ukraine % Argentina % 31 Portugal % Taiwan % Finland % Slovakia % Greece % 32 Korea % Norway % Romania % Finland % South Africa %

16 77 위 - Seoul % 37 위 - Seoul % Clinical trials by city Source: Dec (115773) 2006 (119085) 2007 (115975) 2008 (142597) 2009 ( 96497) 1 New York % New York % 2008 Houston % Houston 변화폭 % Houston % 2 Boston % Houston % New York % New York % New York % 3 Houston % Boston % Boston % Boston % Boston % 4 Chicago % Chicago Japan %(4392) 0.70% Berlin 2.25%(2168) % Berlin -27% % Seoul % 5 Philadelphia % Philadelphia % Chicago % Philadelphia % Berlin % 6 Los Angeles % Baltimore % Philadelphia % Chicago % Philadelphia % 7 Toronto % London Korea %(1582) 0.61% Los Angeles 1.48%(1426) % Los Angeles 33% % Chicago % 8 Atlanta % Dallas % Dallas % Dallas % San Antonio % 9 Seattle % Los Angeles % London % San Antonio % Baltimore % 10 London % Toronto China %(1493) 0.53% San Antonio 1.33%(1283) % London 27% % London % 11 Baltimore % Berlin % Baltimore % Seoul % Paris % 12 Dallas % Atlanta % Rochester % Baltimore % Los Angeles % 13 Portland % Cleveland Russia %(2023) 0.49% Cleveland 1.26%(1217) % Paris -11% % Dallas % 14 Paris % Birmingham % Toronto % Toronto % Toronto % 15 Pittsburgh % San Antonio % Madrid % Atlanta % Cleveland % 16 Rochester % Madrid Australia % 0.46% Moscow 1.11%(1074) % Birmingham - 0% % Rochester % 17 Berlin % Rochester % Seoul % San Diego % Nashville % 18 San Antonio % Moscow % Columbus % Portland % Portland % India 1.05% 0.99%(953) 19 Cleveland % Seattle % Atlanta % Moscow -6% % San Diego % 20 San Diego % Portland % Seattle % Cleveland % Atlanta % 21 Birmingham % Barcelona % Paris % Madrid % Seattle % 22 Denver % Pittsburgh % Barcelona % Columbus % Madrid % 23 Cincinnati % Columbus % Nashville % Seattle % Birmingham % 24 St. Louis % Paris % Birmingham % Cincinnati % Cincinnati % 25 Montreal % Indianapolis % Portland % Nashville % Columbus % 26 Indianapolis % Montreal % Pittsburgh % Rochester % Barcelona % 27 Taipei % Cincinnati % Cincinnati % Barcelona % Moscow % 28 Columbus % Miami % Miami % Miami % Miami % 29 Kansas City % San Diego % San Diego % Indianapolis % St. Louis % 30 Miami % St. Louis % Indianapolis % Pittsburgh % Pittsburgh %

17 Nature of clinical trials in Subtotal Multinational Domestic Subtotal Multinational Domestic Phase Ⅳ Phase Ⅲ Phase Ⅱ Phase Ⅰ

18 Clinical trials by therapeutic category Note: Based on top 500 pharmaceutical and biotech companies, Source: Evaluate Pharma 6Apr2009

19 Oncology trials in Korea Local Multinational KFDA Data

20 Investigator-initiated trials in Korea Numbers of registered trials Year Source:

21 Governmental support of academic clinical trials 2004 MOHW nominated 3 Clinical Research Centers 2008 Total 11 Clinical Research Centers MOHW established NECA MOHW established NSCR under NECA Annual Budget National Strategic Coordination Center for Clinical Research (NSCR) National Evidence-based Healthcare Collaborating Agency (NECA) Total 9,600,000,000 KW (8,300,000 US$) 5,113,000,000 KW (4,500,000 US$) 14,713,000,000 KW (12,800,000 US$)

22 Government-supported clinical research center Name Period 1 Clinical Research Center for Solid Tumor (CRCST) Ischemic Heart Disease Clinical Research Center Clinical Research Center for Chronic Obstructive Airway Disease Korea National Diabetes Program Clinical Research Center for Depression Liver Cirrhosis Clinical Research Center Clinical Research Center for Stroke Clinical Research Center for Dementia Clinical Research Center for the Appropriate Antibiotic Use Clinical Research Center for End Stage Renal Disease Rheumatoid Arthritis Clinical Research Center 08.11

23 Basic research Function of NECA Translational research SIT R&D Health Technology Assessment Program (HTA) Outcomes research HTA Health economic evaluation IIT, pragmatic trials Evidence Clinical practice guideline Practice National Evidencebased Health care Collaborating Agency (NECA) National Strategic Coordination Center for Clinical Research (NSCR)

24 National Strategic Coordination Center for Clinical Research (NSCR) Target Recommendation Topic Selection Public interests Reflect social needs Clinical Trials Clinical Epidemiology Clinical Practice Guideline - Investigator-initiated trial (IIT) - Pragmatic Clinical Trial (PCT) - Registry or cohort study - Merge with public healthcare database Public interests -Registration: Clinicaltrials.gov or equivalent -Data management: evelos or equivalent Data management: evelos or equivalent -Evidence: Systematic review or adaptation -Social Consensus: Appraisal

25 Conclusions There has been a rapid growth in quality and quantity of clinical trials in Korea. Governmental support for infrastructure High-quality medical infrastructure Highly motivated academia Strong points of Korea include Big hospitals with huge patient volume Good infrastructures for medical care and clinical trials Weak points of Korea include Limited governmental support for academic trials Limited reimbursement for clinical trials